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# Stakeholders Hit Generic Drug Labeling Rule
- URL: https://www.fdaweb.com/stakeholders-hit-generic-drug-labeling-rule/
- Published: 2016-04-12T12:00:00.000Z
- Updated: 2026-09-14T20:53:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135332

> Some 15 healthcare stakeholders led by the Generic Pharmaceutical Association and including managed care companies, pharmaceutical benefits managers, and leading drug companies have told FDA that a proposed rule to change generic drug labeling requirements could permit multiple, potentially conflicting labels for therapeutically equivalent products that would create provider and prescriber confusion. A 4/12 [letter](http://www.gphaonline.org/gpha-media/press/healthcare-supply-chain-raises-more-concerns-about-fda-proposed-changes-to-generic-drug-labeling?ref=fdaweb.com) calls on the agency to “use a science-based alternative that relies on FDA to review new safety information for multi-source products. FDA is the only organization in the multi-source environment with full access to complete product safety information from the numerous manufacturers. Therefore, the agency is best positioned to serve as the centralized authority for labeling changes.”  
>  
> The letter cites a 2014 survey of physicians, physician assistants, and pharmacists co-released by the Generic Pharmaceutical Association and the National Coalition on Healthcare that found that:  
> 81% of respondents said that FDA approval should be required before any safety label information is changed; 75% said that patients would be confused by multiple labels for the same medicine; nearly 80% said that multiple labels would be confusing for themselves; and 60% of prescribers said their willingness to prescribe generic drugs would change.